Creating A Healthier Sponsor-Site Dynamic
Why does it seem like problems surface at clinical research sites right about when the study team is either busy preparing for a monitoring visit or immediately following one?
I've seen this many times over the years as both a monitor and monitoring manager, leading me to conclude it's more than purely coincidence. Consider the timing. The greatest interaction between sponsors and sites generally comes during site selection, initiation and activation. However, as the study progresses the frequency of monitoring visits declines − and right along with it − site interactions. This is when problems begin popping up (and multiplying!) like dandelions.
Side effect of RBM tools: A healthier sponsor-site dynamic
They say timing is everything and so it seems with monitoring visits. Without consistent and quality sponsor-site interaction and ongoing guidance, relations can become strained. Fortunately, new technology introduced with risk-based monitoring (RBM) can help strengthen ties, bringing a welcome side effect: a healthier sponsor−site dynamic.
So how can RBM technology positively impact these relationships? What it comes down to is having more consistent, frequent and quality communication. The use of RBM technology-enabling tools (like Compass) can stimulate and support positive interactions between sponsors and sites. One of the chief drivers is the use of an analytics engine to identify issues early, spurring proactive outreach to sites in need of help.
Actionable analytics give sponsors early insights into issues, such as a high rate of adverse events, or a site that's taking too long to submit CRF data. By working to resolve problems together, sponsors and sites are able to enjoy better working relationships.
7 keys to sponsor-site partnering
Create a strong and mutually rewarding relationship and it may extend to future studies:
- Treat each site as a partner. This simple shift in perspective can foster an environment of collaboration and cooperation leading to a successful trial.
- Discuss your monitoring strategy with sites prior to study start and set clear expectations to ensure alignment.
- Discuss what early risk identification looks like and how it is key in helping to avoid the undesirable domino effect, for instance a situation that stems from unknowingly consenting a subject incorrectly and then repeating that incorrect process over and over. Assure sites how this will help them receive the support needed to be successful.
- Identify each site's unique risk factors and needs and use this to inform monitoring priorities.
- Explain what the various forms of sponsor-site interaction will be, for example a combination of on-site visits and ongoing outreach based on performance evidenced in data analytics. This will help maximize your time together and keep focus on issues of greatest need specific to each site.
- Establish frequency and type of interactions and stick to a communications plan outlining how issues will be resolved together with sites.
- Use your RBM technology to the fullest to support both a successful RBM strategy and site relations.
Taking the good with the bad
Unfortunately in the traditional scenario, sites mainly hear from sponsors when problems need to be fixed. This can chip away at these important relationships. Sites continually on the receiving end of negative exchanges may retreat to defensive mode.
Conversely, regular and less "mistake focused" interaction can provide confirmation (and vital positive feedback) acknowledging a site is indeed headed in the right direction – an important factor to staying on track.
Fortunately with the introduction of RBM comes new technology that can maximize sponsor-site interactions through both improved frequency and quality. With Intelligent Monitoring using RBM-enabling technology like Compass, sponsors receive ongoing alerts about site performance on a regular basis, giving them a complete picture of the GOOD along with the bad.
Ongoing communication of not only the negatives, but also the positives, can go a long way toward galvanizing the sponsor-site partnership. This can help avoid what I refer to as "the pre- and post-monitoring visit overload" where sites focus on preparations surrounding an impending or recent monitoring visit as this is their only sponsor interaction.
Using RBM tools can help get everyone on the same page and working toward the same goal.
The use of RBM technology brings with it an exciting opportunity to redefine the sponsor−site dynamic. Drop me a line and let me know what is or is not working in your own studies. I look forward to hearing from sponsors and sites alike.